Orelabrutinib Tablets are an oral small-molecule targeted drug primarily indicated for the treatment of certain types of B-cell lymphoma. It exerts its therapeutic effect by inhibiting the activity of Bruton's tyrosine kinase (BTK), blocking the signal transduction pathway of abnormal B-cell proliferation, and thereby controlling disease progression. Administration must be strictly in accordance with medical advice. The dosage should be adjusted based on the patient's condition, and regular monitoring for adverse reactions is required.
Indications
Orelabrutinib is indicated for adult patients with B-cell malignancies including relapsed or refractory mantle cell lymphoma (MCL), and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The specific eligible population must be determined by the physician based on pathological diagnosis and disease staging.
Dosage and Administration
The recommended dosage is 150 mg administered orally once daily, either with or without food.
Dosage adjustment may be required in cases of hepatic dysfunction, drug interactions, or severe adverse reactions (e.g., bleeding, infection), and must be strictly followed as directed by the physician.
If a dose is missed and less than 12 hours have elapsed since the scheduled time, the missed dose may be taken. Otherwise, the missed dose should be skipped, and the regular dosing schedule should be resumed the next day.
Precautions
Bleeding Risk
The drug may cause thrombocytopenia or coagulation abnormalities. Avoid trauma during treatment. Seek immediate medical attention if abnormal bleeding occurs (e.g., epistaxis, hematuria).
Infection Risk
It may impair immune function, increasing the risk of bacterial, viral, or fungal infections. Monitor body temperature and signs of infection regularly.
Cytopenia
Conduct regular complete blood count (CBC) tests. Symptomatic treatment is required if severe anemia or neutropenia develops.
Arrhythmia
A small number of patients may experience atrial fibrillation or atrial flutter. Enhanced monitoring is recommended for patients with a history of cardiovascular or cerebrovascular diseases.
Contraindications
Contraindicated in patients hypersensitive to orelabrutinib or any of the excipients.
Contraindicated in pregnant or lactating women, as it may cause harm to the fetus or infant.
Drug Interactions
Avoid concomitant use with potent CYP3A4 inhibitors (e.g., ketoconazole) or inducers (e.g., rifampicin), as these may affect drug efficacy or increase toxicity.
Concomitant use with anticoagulants (e.g., warfarin) may increase the risk of bleeding; close monitoring of coagulation function is required.
Adverse Reactions
Common adverse reactions include thrombocytopenia, diarrhea, fatigue, and rash, most of which are mild to moderate in severity. In case of severe adverse reactions (e.g., pneumonia, intracranial hemorrhage), discontinue the drug immediately and seek medical attention.
Storage Conditions
Store below 30℃ protected from light. Keep in the original package to protect from moisture. Keep out of reach of children.
Compliance with the prescribed dosage regimen is essential for safe and effective treatment. Patients should attend regular follow-up visits and truthfully report any medication-related reactions. Do not adjust the dosage or discontinue the drug without medical advice. Seek immediate medical attention if severe discomfort occurs.
